MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN 12 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 228151

Device Problems Positioning Failure (1158); Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The exp date is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 1 of 2 for the same event.It was reported by the sales rep that during a meniscal repair procedure, it was observed that the sales rep's first truespan meniscal repair peek 12 degree deployed the first implant, but misfired on the second implant.When they removed the device from the patient, they noticed the needle was bent.The sales rep stated that the surgeon was likely using too much pressure and bent the needle.The sales rep stated the second truespan meniscal repair peek 12 degree also deployed the first implant then misfired on the second.The sales rep stated the surgeon fully depressed the triggers until the click and penetrated the meniscus to the depth stop.The sales rep stated that the first implants of both devices remain in the patient.The case was completed with two competitor's devices.There was a fifteen minute delay to cut the sutures and open the other devices.The devices are being returned for evaluation.There was patient involvement reported.It was not reported if there was a prolonged hospitalization.The status of the patient post-surgery was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device was received and inspected.The complaint can be confirmed.It was observed that the needle was bent downward.The trigger of the device was fired, confirming that the implants had been deployed.From this operation, it was observed that the deployment needle got stuck inside the sleeve of the device because of the needle being heavily deformed.It was stated by the mitek sales rep that the surgeon was most likely using excessive force when using the device.It is possible that the surgeon fired the first implant successfully, and then leveraged the gun in a way that the needle was bent.When the needle became bent, the sleeve blocked the deployment of the second implant upon being fired therefore causing the device to misfire.However, given the information provided we cannot discern a definitive root cause for the reported failure.A non-conformance search was conducted to investigate any defects during production identified that may contribute to the complaint condition.No non-conformance was identified for this part-lot number combination.At this point, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi:(b)(4).The expiration date is not available.

• Brand Name: TRUESPAN 12 DEGREE PEEK
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8217330
• MDR Text Key: 132076394
• Report Number: 1221934-2019-55910
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026012
• UDI-Public: 10886705026012
• Combination Product (y/n): N
• PMA/PMN Number: K153667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 228151
• Device Lot Number: L863140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention